French eCLIPs™ Efficacy and Safety Investigation

Ki vehet részt

• Patient whose age is greater than 18 years old
• Patient with an unruptured or previously ruptured (at least 1 month from date of rupture and with partial occlusion of the dome of the aneurysm by endovascular techniques or by open neurosurgery, and in stable neurological condition-WFNS I and II with a good recovery to at least to mRS 0-2) saccular, intracranial aneurysm or recurrent aneurysm, which arises at a bifurcation of Basilar Tip or Carotid Terminus with a minimal diameter of 5mm and a maximal diameter <25mm, has a neck length of >4mm or dome:neck ratio <2, branch artery diameters in the range of 2.0mm to 3.25mm
• Patient aneurysm arises at a bifurcation artery with at least one of the two branch artery vessels having a diameter between 2.0mm and 3.25mm
• Patient understands the nature of the procedure and has the capacity to provide informed consent (including fluency in French language)
• Patient is willing to have on-site 30- day, 6-month, and 12 month follow-up evaluations as per standard clinical practice

Ki nem vehet részt

• Patient with an aneurysm deemed to be an eligible candidate for surgical clipping by the investigator
• Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region
• Major surgery within previous 30 days or planned in the next 120 days after enrolment
• Patient with inappropriate anatomy as demonstrated by angiography due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy
• Patient who is currently participating in another clinical research study involving an investigational product
• Patient who has had a previous intracranial procedure associated with the target aneurysm such that access and placement of an eCLIPs™ device would be compromised
• Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to the treatment date
• Subject had a subarachnoid haemorrhage within 1 month prior to enrolment date
• Patient who has participated in a drug study within the last 30 days
• Patient who has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation
• Patient with any condition that, in the opinion of the treating physician, would place the participant at a high risk of embolic stroke or with any medical co-morbidity likely to affect the outcome (e.g. pulmonary disease, uncontrolled diabetes, blood disorders)
• Patient with known allergies to nickel-titanium metal
• Patient with a life threatening allergy to contrast (patients with itching or rash as a reaction to contrast can be included if properly prophylactically treated)
• Unstable neurological deficit (i.e. worsening or improvement of clinical condition in the last 30 days
• Dementia or psychiatric problem that prevents the subject from completing required follow up
• Inability to understand the study or history of non-compliance with medical advice
• Evidence of active infection at the time of treatment
• Patient with an International Normalized Ratio (INR) ≥ 1.5
• Patient with serum creatinine level ≥104 µmol/L (or 2.5mg/dL) at time of enrolment
• Patient with a platelet count ˂100x103 cells/mm3 or known platelet dysfunction at time of enrolment
• Patient with known allergies to aspirin, heparin, ticlopidine, clopidogrel, prasugrel or other anti-platelet or P2Y12 agents or to general anesthesia
• Subject has resistance to P2Y12 agents based on a validated platelet testing method (Verify Now, Multiplate or other)
• Patient over the age of majority benefiting from legal protection (guardianship, curatorship, safeguard of justice)
• More than one intracranial aneurysm that requires treatment within 12 months
• Asymptomatic extradural aneurysms requiring treatment
• Severe neurological deficit that renders the subject incapable of living independently
• Subject has a non-treated arterio-venous malformation in the territory of the target aneurysm
• Subject has a need for long-term use of anticoagulants
• Patient who is unable to complete the required follow-up
• Patient who is pregnant or breastfeeding